Overview of the Omnipod 5 System Pivotal Clinical Study 25
286
25 Overview of the Omnipod 5 System Pivotal Clinical Study
25.1. Studies in Children, Adolescents and Adults with
Type 1 Diabetes
Omnipod 5 Pivotal Study in Children, Adolescents and
Adults (6-70 years)
e goal of the US-based pivotal study of the Omnipod 5 System was to assess the
safety and eectiveness of the system. is single-arm, multicentre, prospective
study enrolled 112 children (6 to 13.9 years) and 128 adolescents and adults (14 to
70 years). A 2-week standard-therapy phase (usual insulin regimen) was followed
by 3 months of Omnipod 5 System use in Automated Mode. e primary analysis
consisted of A1C and sensor glucose time in range (3.9–10 mmol/L, 70–180
mg/dL) results. e primary safety endpoints included an assessment of severe
hypoglycaemia and diabetic ketoacidosis (DKA) events. An analysis of the
secondary endpoints and additional metrics was also performed. An analysis of
the primary, secondary and safety results are presented in the tables below.
Of the 240 participants enrolled, 98% completed the trial (111 children and
124 adolescents and adults). e study population consisted of people with type
1 diabetes for at least 6 months. All participants were required to have an A1C
<10.0% at screening. Participants <18 years had to be living with a parent or legal
guardian. No participants with the following conditions were enrolled:
• History of severe hypoglycaemia or DKA in the past 6 months
• Sickle cell disease, adrenal insuciency, eating disorder, abnormal kidney
function (eGFR <45), haemophilia or any other bleeding disorders, untreated
thyroid disease
• History of cardiovascular disease including coronary artery disease, heart
attack and cardiac intervention procedure or coronary bypass surgery in the
past year
• Abnormal ECG in participants >50 years or diagnosed with diabetes
>20 years
• Plans to receive a blood transfusion during the study
• Taking oral or injectable steroids or diabetes medications other than
metformin and insulin
• Pregnant or lactating women
e safety and eectiveness of the Omnipod 5 System in users with the conditions
above is unknown. Please note that the study exclusion list above is condensed
and does not include every exclusion criterion. e trial was registered at
clinicaltrials.gov, a national database of clinical trials in the United States, with ID
number NCT04196140. Full details of the study criteria can be found there.
To Next Page
Loading...
